Devices for applying energy to tissue

ABSTRACT

Disclosed herein are devices for altering gaseous flow within a lung to improve the expiration cycle of an individual, particularly individuals having Chronic Obstructive Pulmonary Disease (COPD). More particularly, devices are disclosed to produce collateral openings or channels through the airway wall so that expired air is able to pass directly out of the lung tissue to facilitate both the exchange of oxygen ultimately into the blood and/or to decompress hyper-inflated lungs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.09/946,706 filed Sep. 14, 2001, now issued as U.S. Pat. No. 6,749,606,which is a continuation-in-part of U.S. application Ser. No. 09/906,087filed Jul. 18, 2001, which is a continuation of U.S. application Ser.No. 09/633,651 filed Aug. 7, 2000, now issued as U.S. Pat. No.6,692,494, which claims benefit of U.S. Nonprovisional applications60/176,141 filed Jan. 14, 2000, and 60/147,528 filed Aug. 5, 1999. U.S.Pat. No. 6,749,606 (U.S. application Ser. No. 09/946,706) is also claimsbenefit of U.S. Nonprovisional applications 60/269,130 filed Feb. 14,2001.

FIELD OF THE INVENTION

The invention is directed to devices for altering gaseous flow within alung to improve the expiration cycle of an individual, particularlyindividuals having Chronic Obstructive Pulmonary Disease (COPD). Moreparticularly, devices are disclosed to produce collateral openings orchannels through the airway wall so that expired air is able to passdirectly out of the lung tissue to facilitate both the exchange ofoxygen ultimately into the blood and/or to decompress hyper-inflatedlungs. The invention is also directed to medical kits for maintainingcollateral openings through airway walls.

BACKGROUND OF THE INVENTION

The term “Chronic Obstructive Pulmonary Disease” (COPD) is generallyused to describe the disorders of emphysema and chronic bronchitis.Previously, COPD was also known as Chronic Obstructive Lung Disease(COLD), Chronic Airflow Obstruction (CAO), or Chronic Airflow Limitation(CAL). Some also consider certain types of asthma to fall under thedefinition of COPD. Emphysema is characterized by an enlargement of airspaces inside the lung. Hence, emphysema is an anatomic definition andit can only be presumed in a living patient. Chronic bronchitis ischaracterized by excessive mucus production in the bronchial tree.Chronic bronchitis is a clinical definition and denotes thoseindividuals who meet criteria defining the disease. It is not uncommonfor an individual to suffer from both disorders.

In 1995, the American Lung Association (ALA) estimated that between15–16 million Americans suffered from COPD. The ALA estimated that COPDwas the fourth-ranking cause of death in the U.S. The ALA estimates thatthe rates of emphysema is 7.6 per thousand population, and the rate forchronic bronchitis is 55.7 per thousand population.

Those inflicted with COPD face disabilities due to the limited pulmonaryfunctions. Usually, individuals afflicted by COPD also face loss inmuscle strength and an inability to perform common daily activities.Often, those patients desiring treatment for COPD seek a physician at apoint where the disease is advanced. Since the damage to the lungs isirreversible, there is little hope of recovery. Most times, thephysician cannot reverse the effects of the disease but can only offertreatment and advice to halt the progression of the disease.

To understand the detrimental effects of COPD, the workings of the lungsrequires a cursory discussion. The primary function of the lungs is topermit the exchange of two gasses by removing carbon dioxide from venousblood and replacing it with oxygen. Thus, to facilitate this exchange,the lungs provide a blood gas interface. The oxygen and carbon dioxidemove between the gas (air) and blood by diffusion. This diffusion ispossible since the blood is delivered to one side of the blood-gasinterface via small blood vessels (capillaries). The capillaries arewrapped around numerous air sacs called alveoli which function as theblood-gas interface. A typical human lung contains about 300 millionalveoli.

The air is brought to the other side of this blood-gas interface by anatural respiratory airway, hereafter referred to as a natural airway orairway, consisting of branching tubes which become narrower, shorter,and more numerous as they penetrate deeper into the lung. Specifically,the airway begins with the trachea which branches into the left andright bronchi which divide into lobar, then segmental bronchi.Ultimately, the branching continues down to the terminal bronchioleswhich lead to the alveoli. Plates of cartilage may be found as part ofthe walls throughout most of the airway from the trachea to the bronchi.The cartilage plates become less prevalent as the airways branch.Eventually, in the last generations of the bronchi, the cartilage platesare found only at the branching points. The bronchi and bronchioles maybe distinguished as the bronchi lie proximal to the last plate ofcartilage found along the airway, while the bronchiole lies distal tothe last plate of cartilage. The bronchioles are the smallest airwaysthat do not contain alveoli. The function of the bronchi and bronchiolesis to provide conducting airways that lead inspired air to the gas-bloodinterface. However, these conducting airways do not take part in gasexchange because they do not contain alveoli. Rather, the gas exchangetakes place in the alveoli which are found in the distal most end of theairways.

The mechanics of breathing include the lungs, the rib cage, thediaphragm and abdominal wall. During inspiration, inspiratory musclescontract increasing the volume of the chest cavity. As a result of theexpansion of the chest cavity, the pleural pressure, the pressure withinthe chest cavity, becomes sub-atmospheric with respect to the pressureat the airway openings. Consequently, air flows into the lungs causingthe lungs to expand. During unforced expiration, the expiratory musclesrelax and the lungs begin to recoil and reduce in size. The lungs recoilbecause they contain elastic fibers that allow for expansion, as thelungs inflate, and relaxation, as the lungs deflate, with each breath.This characteristic is called elastic recoil. The recoil of the lungscauses alveolar pressure to exceed the pressure at airway openingscausing air to flow out of the lungs and deflate the lungs. If thelungs'ability to recoil is damaged, the lungs cannot contract and reducein size from their inflated state. As a result, the lungs cannotevacuate all of the inspired air.

In addition to elastic recoil, the lung's elastic fibers also assist inkeeping small airways open during the exhalation cycle. This effect isalso known as “tethering” of the airways. Such tethering is desirablesince small airways do not contain cartilage that would otherwiseprovide structural rigidity for these airways. Without tethering, and inthe absence of structural rigidity, the small airways collapse duringexhalation and prevent air from exiting thereby trapping air in withinthe lung.

Emphysema is characterized by irreversible biochemical destruction ofthe alveolar walls that contain the elastic fibers, called elastin,described above. The destruction of the alveolar walls results in a dualproblem of reduction of elastic recoil and the loss of tethering of theairways. Unfortunately for the individual suffering from emphysema,these two problems combine to result in extreme hyperinflation (airtrapping) of the lung and an inability of the person to exhale. In thissituation, the individual will be debilitated since the lungs are unableto perform gas exchange at a satisfactory rate.

One further aspect of alveolar wall destruction is that the airflowbetween neighboring air sacs, known as collateral ventilation orcollateral air flow, is markedly increased as when compared to a healthylung. While alveolar wall destruction decreases resistance to collateralventilation, the resulting increased collateral ventilation does notbenefit the individual since air is still unable to flow into and out ofthe lungs. Hence, because this trapped air is rich in CO2, it is oflittle or no benefit to the individual.

Chronic bronchitis is characterized by excessive mucus production in thebronchial tree. Usually there is a general increase in bulk(hypertrophy) of the large bronchi and chronic inflammatory changes inthe small airways. Excessive amounts of mucus are found in the airwaysand semisolid plugs of this mucus may occlude some small bronchi. Also,the small airways are usually narrowed and show inflammatory changes.

Currently, although there is no cure for COPD, treatment includesbronchodilator drugs, and lung reduction surgery. The bronchodilatordrugs relax and widen the air passages thereby reducing the residualvolume and increasing gas flow permitting more oxygen to enter thelungs. Yet, bronchodilator drugs are only effective for a short periodof time and require repeated application. Moreover, the bronchodilatordrugs are only effective in a certain percentage of the population ofthose diagnosed with COPD. In some cases, patients suffering from COPDare given supplemental oxygen to assist in breathing. Unfortunately,aside from the impracticalities of needing to maintain and transport asource of oxygen for everyday activities, the oxygen is only partiallyfunctional and does not eliminate the effects of the COPD. Moreover,patients requiring a supplemental source of oxygen are usually neverable to return to functioning without the oxygen.

Lung volume reduction surgery is a procedure which removes portions ofthe lung that are over-inflated. The improvement to the patient occursas a portion of the lung that remains has relatively better elasticrecoil which allows for reduced airway obstruction. The reduced lungvolume also improves the efficiency of the respiratory muscles. However,lung reduction surgery is an extremely traumatic procedure whichinvolves opening the chest and thoracic cavity to remove a portion ofthe lung. As such, the procedure involves an extended recovery period.Hence, the long term benefits of this surgery are still being evaluated.In any case, it is thought that lung reduction surgery is sought inthose cases of emphysema where only a portion of the lung isemphysematous as opposed to the case where the entire lung isemphysematous. In cases where the lung is only partially emphysematous,removal of a portion of emphysematous lung increases the cavity area inwhich the non-diseased parenchyma may expand and contract. If the entirelung were emphysematous, the parenchyma is less elastic and cannotexpand to take advantage of an increased area within the lung cavity.

Both bronchodilator drugs and lung reduction surgery fail to capitalizeon the increased collateral ventilation taking place in the diseasedlung. There remains a need for a medical procedure that can alleviatesome of the problems caused by COPD. There is also a need for a medicalprocedure that alleviates some of the problems caused by COPDirrespective of whether a portion of the lung, or the entire lung isemphysematous.

The present invention addresses the problems caused by COPD by providinga device configured to create collateral openings through an airway wallwhich allows expired air to pass directly out of the lung tissueresponsible for gas exchange. These collateral openings ultimatelydecompress hyper-inflated lungs and/or facilitate an exchange of oxygeninto the blood.

Furthermore, there is also a need for devices that are able to accessremote areas of the body to provide dual functions of locating anacceptable site for removal or cutting of tissue and then removing orcutting the tissue without having to reposition the device. Such a needis evident in dynamically moving environments (e.g., the lungs) whererepositioning of a device to find the original target site may bedifficult.

Doppler ultrasound is an effective means to determine the presence orabsence of a blood vessel within tissue. It is known that sound waves atultrasonic frequencies travel through tissue and reflect off ofobjects/interfaces where density gradients exist. In which case, thereflected signal and the transmitted signal will have the samefrequency. Alternatively, in the case where the signal is reflected fromthe blood cells moving through a blood vessel, the reflected signal willhave a shift in frequency from the transmitted signal. This shift isknown as a Doppler shift. However, since the characteristics ofcomponents used to detect Doppler shift vary from characteristics ofcomponents used to cut or remove tissue, it is difficult to cut orremove tissue in precisely the same location and immediately afterdetection has taken place. It is usually required that the component ordevice used to detect any Doppler shift first must be moved to allow asecond component or device to cut or remove the tissue at the sameprecise location.

For instance, if a device uses energy to create an opening or ablatetissue, the energy delivery components may not have acceptablecharacteristics to also serve as Doppler components. Furthermore, theprocess of delivering energy through the device may undesirably impactany Doppler components.

When using Doppler in tissue it is noted that the acoustic impedance ofthe ultrasound transducer and the acoustic impedance of tissue differsignificantly. As a result, the ultrasound signal may experiencesignificant reflection and divergence at the tissue/transducerinterface. To address this issue, a tip or lens may be used as aninterface between the transducer and tissue.

In common Doppler ultrasound applications, a tip material is selected toprovide an optimum acoustic match between the ultrasonic transducer andtissue. This optimum acoustic match is the geometric mean impedancebetween the tissue and the transducer material, governed by thefollowing equation.Z _(optimum)=(Z _(tissue) ×Z _(transducer))^(½)

Where Z_(optimum) is the desired acoustic impedance of the tip material;Z_(tissue) is the acoustic impedance of tissue; and Z_(transducer) isthe acoustic impedance of the transducer. Generally, Z_(tissue) rangesfrom 1.38 MRayls (for fat) to 1.70 MRayls (for muscle), whileZ_(transducer) is approximately 30 MRayls for ceramic transducermaterials. Therefore, using Z_(transducer) of 1.54 MRayls (the averageacoustic impedance for tissue) the desirable tip material should have anacoustic impedance around 6.79 MRayls.

Most materials having an acoustic impedance close to this range are madeof epoxy composites and range from, for example, 1.78 MRayls for amethylpentene copolymer (e.g., TPX, Matsui Plastics, White Plains, N.Y.)to 4.39 MRayls for high temperature plastics (e.g., CELAZOLE, CurbellPlastics, Glenshaw, Pa.).

One drawback to using Doppler ultrasound devices for placing collateralopenings in tissue is that conventional tip materials selected for theirdesirable acoustic impedance are not effective to deliver energy (e.g.,RF, resistive heat, etc.) The acoustic impedance of electrically andthermally conductive materials is higher than the desired acousticimpedance of 6.79 MRayls. For example, Z_(aluminum) is approximately 18MRayls, Z_(titanium) is approximately 27 MRayls, and Z_(stainless steel)is approximately 45 MRayls.

Another drawback to delivering energy through devices configured forDoppler applications is that the transducer is prone to being damaged.For example, when used to deliver therapeutic RF energy, an electricallyconductive tip experiences heating. If a sufficient amount of heat isconducted from the tip, the transducer may depolarize. Moreover,conduction of heat through the device may adversely affect the jointsand bonds between the transducer, tip and device. As a result, there isthe potential of a catastrophic failure of the device if the assemblybreaks apart during use in the body.

In view of the above, the present invention provides a device capable oflocating an acceptable site for the creation of a collateral opening andthen creating an opening in the tissue using a device capable of bothfunctions. While the present invention is discussed as havingapplicability to creation of collateral openings it was found to haveutility for other applications as well. For example, the presentinvention is suited for the application of energy to tissue in a safemanner (e.g., tumor ablation, tissue removal, application of heat tostructures within the body, etc.). Especially when there is a need toavoid blood vessels, or other tissue/organs/structures. The inventionhas applicability given a need to use of Doppler effect to locatemovement within tissue and then apply energy based on the observation ofthe Doppler effect.

Methods and devices for creating, and maintaining collateral channelsare discussed in U.S. patent application Ser. No. 09/633,651, filed onAug. 7, 2000; U.S. patent application Ser. Nos. 09/947,144, 09/946,706,and 09/947,126 all filed on Sep. 4, 2001; U.S. Provisional ApplicationNo. 60/317,338 filed on Sep. 4, 2001, and 60/334,642 filed on Nov. 29,2001, whereas the entirety of each listed application is incorporated byreference herein.

SUMMARY OF THE INVENTION

The invention related to devices for applying energy to tissue. Theinvention includes an elongate member having a proximal portion and adistal portion; a transducer assembly and an electrically conductivehollow member located at a distal end of the outer sheath that iscoupled to an energy source.

The invention may include a tip having a front and back surface, theback surface being in acoustical communication with the transducerassembly wherein the tip is adapted to communicate a source signal fromthe transducer assembly out through the front surface, the tip alsobeing adapted to communicate a reflected signal from the front surfaceto the transducer; and at least two conducting members extending throughat least a portion of the elongate member.

The tip of the device functions to direct signals to and from thetransducer assembly. The hollow electrically conductive member whichcuts or removes tissue via conducting electro-surgical energy (e.g., RFenergy) to desired areas. The hollow member can also remove or cuttissue via resistive heating or mechanical cutting.

The invention further includes transducer assemblies wherein thetransducer assembly comprises a covering having a proximal and distalend, at least one transducer having at least a first and second pole, afirst conductive medium in contact with the first pole of the transducerand extending to at least a portion of an outer surface of the covering,and wherein at least a first of the conducting members is electricallycoupled to the first conductive medium, and a second of the conductingmembers extends through the proximal end of the covering andelectrically couples to the second pole of the transducer.

The invention may include insulating layers that serve to protect tissueand/or parts of the device from unwanted heating. The elongate member ofthe device may also serve as the insulating layer or as additionalinsulation.

The invention also includes a transducer assembly that is configured tominimize the size of the device so that it may access deeper regions ofthe body (e.g., deeper regions of airways in the lungs). The transducerassembly may include a covering that is either conductive or is coveredby a conductive medium. As such, the covering (or conductive medium)provides an electrical path to a pole of the transducer, therebyeliminating the need for a separate electrical connection.

The invention also includes a medical device for detecting Doppler shiftand for applying energy to tissue, the medical device comprising anelongate member having a proximal portion and a distal portion; atransducer means (e.g., a transducer assembly as described herein) forgenerating a source signal and for receiving a reflected signal whereinthe transducer means is located towards the distal portion of theelongate member; a directing means (e.g., a tip as described herein) fordirecting the source signal and the reflected signal, the directingmeans located adjacent to and being in acoustical communication with thetransducer means, a first conducting member and a second conductingmember both extending from the proximal portion of the elongate memberto the distal portion of the elongate member, the conducting memberselectrically coupled to at least the transducer assembly, and anenergy-conducting means (e.g., an electrically conductive member) forapplying energy to tissue, the energy-conducting means located exteriorto the transducer means and the signal directing means.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A–1C illustrate various states of the natural airways and theblood-gas interface.

FIG. 1D illustrates a schematic of a lung demonstrating a principle ofthe effect of collateral channels placed therein.

FIG. 2A is a sectional view of a variation of the invention having aconductive member which creates the collateral channel.

FIG. 2B is a sectional view of another variation of the invention havinga conductive member.

FIGS. 2C–2D illustrate another variation of the invention.

FIGS. 3A–3B illustrate cross sectional views of examples of transducerassemblies of the present invention.

FIGS. 4A–4D illustrate examples of tip configurations of the presentinvention.

FIGS. 5A–5E illustrate various configurations to retain a tip to devicesof the present invention.

FIGS. 6A–6B illustrate insulating layers on the device.

FIG. 7A illustrates a variation of the device where the outer sheath isused to create a redundant joint to retain a hollowelectrically-conductive member on the device. FIG. 7B is a crosssectional view taken along the line 7B—7B of FIG. 7A.

FIGS. 8A–8C shows the device when used to create a collateral channel inthe airways of the lung.

DETAILED DESCRIPTION OF THE INVENTION

Prior to considering the invention, simplified illustrations of variousstates of a natural airway and a blood gas interface found at a distalend of those airways are provided in FIGS. 1A–1C. FIG. 1A shows anatural airway 100 which eventually branches to a blood gas interface102. FIG. 1B illustrates an airway 100 and blood gas interface 102 in anindividual having COPD. The obstructions 104 (e.g., excessive mucusresulting from COPD, see above) impair the passage of gas between theairways 100 and the interface 102. FIG. 1C illustrates a portion of anemphysematous lung where the blood gas interface 102 expands due to theloss of the interface walls 106 which have deteriorated due to abio-chemical breakdown of the walls 106. Also depicted is a constriction108 of the airway 100. It is generally understood that there is usuallya combination of the phenomena depicted in FIGS. 1A–1C. More usually,the states of the lung depicted in FIGS. 1B and 1C are often found inthe same lung.

The following illustrations are examples of the invention describedherein. It is contemplated that combinations of aspects of specificembodiments/variations or combinations of the specificembodiments/variations themselves are within the scope of thisdisclosure.

As will be explained in greater detail below, the production andmaintenance of collateral openings or channels through airway wallspermits expired air to pass directly out of the lung tissue and into theairways to ultimately facilitate exchange of oxygen into the bloodand/or decompress hyper inflated lungs. The term ‘lung tissue’ isintended to include the tissue involved with gas exchange, including butnot limited to, gas exchange membranes, alveolar walls, parenchymaand/or other such tissue. To accomplish the exchange of oxygen, thecollateral channels allow fluid communication between an airway and lungtissue. Therefore, gaseous flow is improved within the lung by alteringor redirecting the gaseous flow within the lung, or entirely within thelung.

FIG. 1D illustrates a schematic of a lung 118 to demonstrate a benefitof the production and maintenance of collateral openings or channelsthrough airway walls. As shown, a collateral channel 112 (located in anairway wall 110) places lung tissue 116 in fluid communication withairways 100 allowing expired air to directly pass out of the airways100. The term channel is intended to include an opening, cut, slit,tear, puncture, or any other conceivable artificially created opening.As shown, constricted airways 108 may ordinarily prevent air fromexiting the lung tissue 116. In the example illustrated in FIG. 1D,there is no implanted structure placed in the collateral channel 112.However, conduits (not shown) may be placed in the collateral channels112 to assist in maintaining the patency of the collateral channels 112.Examples of conduits may be found in the applications discussed above.While there is no limit to the number of collateral channels which maybe created, it is preferable that 1 or 2 channels are placed per lobe ofthe lung. For example, the preferred number of channels is 2–12 channelsper individual patient. In current trials, it was found that 1–4channels placed per lobe of the lung and 4–16 channels per individualpatient was preferable. This number may vary on a case by case basis.For instance, in some cases an emphysematous lung may require 3 or morecollateral channels in one or more lobes of the lung.

In the following explanation of figures, similar numerals may representsimilar features for the different variations of the invention.

The invention herein is described by examples and a desired way ofpracticing the invention is described. However, the invention as claimedherein is not limited to that specific description in any manner.Equivalence to the description as hereinafter claimed is considered tobe within the scope of protection of this patent.

The devices of the present invention are configured to locate a targetsite for creation of a collateral channel in the tissue and to create anopening in tissue. As discussed above, a benefit of this combinationfeature is that a single device is able to select a target location andthen create an opening without having been moved. Although the device isdiscussed as being primarily used in the lungs, the device is notlimited as such and it is contemplated that the invention has utility inother areas as well, specifically in applications in which blood vesselsor other structures must be avoided while cutting or removing tissue(one such example is tumor removal.)

The present invention includes the use of a device which is able todetect the presence or absence of a blood vessel by placing a frontportion of the device in contact with tissue. One variation of theinvention includes the use of Doppler ultrasound to detect the presenceof blood vessels within tissue. However, the frequency of the signals isnot limited to the ultrasonic range, for example the frequency may bewithin the range of human hearing, etc.

The ultrasound Doppler operates at any frequency in the ultrasound rangebut preferably between 2 Mhz–30 Mhz. It is generally known that higherfrequencies provide better resolution while lower frequencies offerbetter penetration of tissue. In the present invention, because locationof blood vessels does not require actual imaging, there may be a balanceobtained between the need for resolution and for penetration of tissue.Accordingly, an intermediate frequency may be used (e.g., around 8 Mhz).A variation of the invention may include inserting a fluid into theairway to provide a medium for the Doppler sensors to couple to the wallof the airway to detect blood vessels. In those cases where fluid is notinserted, the device may use mucus found within the airway to directlycouple the sensor to the wall of the airway.

FIG. 2A illustrates a sectional side view of a variation of theinventive device 200. The device 200 includes a transducer assembly 202(variations of which are described in more detail below.) As shown inthe figure, a tip 204 is adjacent to the transducer assembly 202. It iscontemplated that, throughout this disclosure, the transducer assembly202 may be a transducer or a transducer coupled with a covering andother components (examples of which are discussed below). Furthermore,the inventive device 200 may be used without a tip 204. A portion of thetransducer assembly 202 is located towards a distal portion of anelongate member 218. The transducer assembly of any variation of thepresent invention may be located within the elongate member, or it maybe located within a portion of the tip of the device. In any case, thetransducer assembly will be located towards the distal portion of theelongate member. The elongate member described herein may be comprisedof any commercially available medical-grade flexible tubing.Furthermore, the elongate member may be selected from material thatprovides insulation from the heat generated by the device. For example,the elongate member may comprise a PTFE material. In such cases, theelongate member will provide insulation for tissue that is adjacent tothe area where creation of a collateral channel is desired. Also, insome cases, insulation may be required to prevent damage to thetransducer assembly.

The device 200 further includes a first conducting member 220 and asecond conducting member 222 (e.g., wires) both extending through atleast a portion of elongate member 218 to the transducer assembly 202.The conducting members 220, 222 may extend through the lumen of theelongate member 218 or may extend in the wall of the elongate member218. In any case, the conducting members 220, 220 provide the energy andcontrols 190 for the transducer assembly 202. For example, theconducting members 220, 222 may be coupled to an ultrasound source 190.Moreover, variations of the inventive device include conducting members220, 222 which may be comprised of a series of wires, with one set ofwires being coupled to respective poles of the transducer, and anynumber of additional sets of wires extending through the device.Ultimately, the wires enable the device to couple to energy and controlunits. Although not illustrated, the device 200 may also include anouter sheath (not shown in FIG. 2A) in which the device 200 may beadvanced to a target tissue site.

In the variation depicted in FIG. 2A, the device 200 includes a hollowelectrically-conductive member 224 (e.g., a stainless steel thin walledtubing such as a hypo-tube, cannula tubing such as that used forneedles, etc.). The hollow electrically-conductive member 224 is coupledto an energy source 188 (e.g., a monopolar or bi-polar RF energysource.) Accordingly, the hollow electrically-conductive member 224 maybe used to remove or cut tissue (e.g., to create a collateral channel)once the ultrasound assembly 202 is used to find an acceptable locationfor placement of the collateral channel. The hollowelectrically-conductive member 224 may be coupled to the energy source188 via a third conductive member 250. Alternatively, the hollowelectrically-conductive member 224 may be coupled to the energy source188 via other means (e.g., use of one of the conducting members coupledto the transducer assembly.) It should be noted that the hollowelectrically-conductive member 224 may be insulated such that only adistal portion of the member 224 is enabled to create a collateralchannel. Such a configuration may better direct heat or current (i.e.,if used as an RF device) to the desired location.

In the variation depicted in FIG. 2A, the transducer assembly 202 andelongate member 218 may be slidably located in the hollowelectrically-conductive member 224. Therefore, when the conductivemember 224 is used to create a collateral channel, it may be desirableto space the transducer assembly 202 a sufficient distance from theconductive member 224 to prevent damage to the assembly 202. The degreeof spacing will depend upon the duration and amount of energy applied.The sliding actuation of the device may be automated or manual. In asimple variation, one member may be slidable to another via use of aknob that permits relative movement between the components. Furthermore,it may be desirable to allow the operator of the device to actuate thecomponents with a single hand.

FIG. 2B illustrates another variation of a device 200 for creatingcollateral channels. In this variation, a transducer assembly 202 isprovided with a tip 204. It should be noted that the shape of the tipsillustrated in the figures is not meant to be limiting. Rather, the tipshapes shown are for illustration purposes only. The tip 204 is locatedadjacent to the transducer assembly 202. A portion of the transducerassembly 202 may be located towards a distal portion of an elongatemember 218. As stated above, the transducer assembly of any variation ofthe present invention may be located within the elongate member, or itmay be located within a portion of the tip of the device. In thevariation depicted in FIG. 2B the device 200 also includes an (optional)outer sheath 226. As illustrated, the device includes a hollowelectrically-conductive member 224 coupled to an energy source 188 usinga third conducting member 250

FIG. 2C illustrates another variation of the inventive device 200 wherea hollow electrically-conductive member 224 is exterior to a transducerassembly 202. In this variation, the transducer assembly 202 comprises atransducer. The hollow electrically-conductive member 224 may be eitheran RF device or a resistive heating device. Alternatively, the hollowmembers 224 of the present invention may be mechanical devices thatsimply cut the tissue. For example, the hollow electrically-conductivemember 224 can be a hypo-tube placed over the transducer assembly 202.In this variation of the device 200, the transducer assembly 202 may bemoveable within the hollow electrically-conductive member 224, or thehollow electrically-conductive member 224 may be moveable over thetransducer assembly 202. In either case, the transducer assembly 202 maybe advanced out of hollow electrically-conductive member 224 todetermine the presence of a blood vessel. If no blood vessel is found,the transducer assembly 202 may be withdrawn into the hollowelectrically-conductive member 224 allowing the it to cut or removetissue. FIG. 2D illustrates a view taken along the line 2D in FIG. 2C.

Although FIGS. 2A–2C illustrate the inventive device 200 as having atransducer assembly 202 and tip 204 that are slidable relative to theconductive member 224, it is noted that the conductive member 224 may befixed relative to the tip 204 or the transducer assembly 202. In such acase, the conductive member 224 will be fixed such that the tip 204 ofthe device 200 is able to contact tissue while the conductive member 224is either slightly behind the front surface of the tip 204 or theconductive member 224 is already engaging the tissue. After determiningthat energy may be applied, the entire device 200 with the fixedconductive member 224 may be advanced to permit the conductive member224 to remove tissue.

Although the transducer assembly is adapted to generate a source signaland receive a reflected signal, variations of the invention may omit thetransducer covering and other structures not necessary to generate asource signal and receive a reflected signal. Therefore, it iscontemplated that the invention may simply have a transducer that iscoupled to a controller.

As discussed herein, for some variations of the invention it isdesirable to minimize the size of the device especially at the distalend. Although the invention may be any size, it was found that anoverall device diameter of 0.071″ was acceptable. As noted, because thedevice is advanced through the airways, the device may treat deeperareas in the airways of the lungs given a smaller outside diameter ofthe distal end of the device. This size also permits delivery of thedevice into the lungs through the working channel of a standardbronchoscope or endoscope. However, this reduction in size is limited asfunctionality of the device may suffer. For example, one or more wireswill be selected such that they will deliver sufficient RF energy over adesired period of time without experiencing unacceptable heating.Therefore, the smallest acceptable cross sectional area of a single wireor multiple wires will be a balance of the energy delivery requirementsof the device versus the characteristics of the wire or wires.

FIGS. 3A–3B illustrate variations of the transducer assembly 202 whichare configured to reduce an overall size of the assembly. FIG. 3Aillustrates a cross-sectional view of a basic variation of a transducerassembly 202 for use with the present invention. For illustrationpurposes, the transducer assembly 202 illustrated in FIG. 3A is shownwithout a tip. The transducer assembly 202 includes at least onetransducer 208 (e.g., a piezoelectric transducer.) In this variation,the front surface of the transducer 208 comprises a first pole and therear surface comprises a second pole.

The transducer or transducers may comprise a piezo-ceramic crystal(e.g., a Motorola PZT 3203 HD ceramic). In the current invention, asingle-crystal piezo (SCP) is preferred, but the invention does notexclude the use of other types of ferroelectric material such aspoly-crystalline ceramic piezos, polymer piezos, or polymer composites.The substrate, typically made from piezoelectric single crystals (SCP)or ceramics such as PZT, PLZT, PMN, PMN-PT; also, the crystal may be amulti layer composite of a ceramic piezoelectric material. Piezoelectricpolymers such as PVDF may also be used. Micromachined transducers, suchas those constructed on the surface of a silicon wafer are alsocontemplated (e.g., such as those provided by Sensant of San Leandro,Calif.) As described herein, the transducer or transducers used may beceramic pieces coated with a conductive coating, such as gold. Otherconductive coatings include sputtered metal, metals, or alloys, such asa member of the Platinum Group of the Periodic Table (Ru, Rh, Pd, Re,Os, Ir, and Pt) or gold. Titanium (Ti) is also especially suitable. Thetransducer may be further coated with a biocompatible layer such asParylene or Parylene C.

The covering 206 of the transducer assembly 202 may contain at least aportion of the transducer 208. In some variations of the invention, thecovering 206 may comprise a conductive material. In such cases thecovering 206 itself becomes part of the electrical path to the firstpole of the transducer 208. Use of a conductive covering 206 may requireinsulating material 213 between the sides of the transducer 208, therebypermitting a first conductive medium 214 to electrically couple only onepole of the transducer 208 to the covering 206.

At least a portion of the front surface of the transducer 208, will bein contact with the conductive medium 214. The conductive medium 214permits one of the poles of the transducer 208 to be placed incommunication with a conducting member that is ultimately coupled to apower supply. As shown in this example, the conductive medium 214 placesthe pole of the transducer 208 in electrical communication with thecovering 206. In some variations the conductive medium 214 may coat theentire transducer 208 and covering 206. Alternatively, the conductivemedium 214 may be placed over an area small enough to allow for anelectrical path between a conducting member and the respective pole ofthe transducer 208. The conductive medium 214 may be any conductivematerial (e.g., gold, silver, tantalum, copper, chrome, or anybio-compatible conductive material, etc. The material may be coated,deposited, plated, painted, wound, wrapped (e.g., a conductive foil),etc. onto the transducer assembly 202.

The transducer assembly 202 depicted in FIG. 3A also illustratesconducting members 220, 222 electrically coupled to respective poles ofthe transducer 208. Optionally, the conducting members 220, 222 may beencapsulated within an epoxy 211 located within the covering 206. Theepoxy 211 may extend to the transducer 208 thereby assisting inretaining both the conducting members 220, 222 and transducer 208 withinthe covering. It may also be desirable to maintain a gap 228 between thetransducer 208 and any other structure. It is believed that this gap 228improves the ability of the transducer assembly 202 to generate asignal.

FIG. 3B illustrates another variation of a transducer assembly 202. Inthis variation, the conductive medium 214 extends over the entiretransducer covering 206. Accordingly, the covering 206 may be made of anon-conducting material (e.g., a polyamide tube, polyetherimide,polycarbonate, etc.) The transducer assembly 202 may further comprise asecond tube 216 within the covering 206. This second tube 216 may be ahypo-tube and may optionally be used to electrically couple one of theconducting members to a pole of the transducer 208. As shown, thecovering 206 may contain a non-conductive epoxy 210 (e.g., Hysol2039/3561 with Scotchlite glass microspheres B23/500) which secures boththe conducting member and the second tube 216 within the covering 206.This construction may have the further effect of structurally securingthe transducer 208 within the assembly 202. Again, a gap 228 may or maynot be adjacent to the transducer to permit displacement of thetransducer 208.

FIG. 3B also illustrates the assembly 202 as having a conductive epoxy212 which encapsulates the alternate conducting member 220. An exampleof a conductive epoxy is Bisphenol epoxy resin with silver particulatesto enable conductivity. The particulates may be from 70–90% of the resincomposition. The resin may then be combined with a hardener (e.g., 100parts resin per 6 parts hardener.) The conductive epoxy 212 is inelectrical communication with the conductive medium 214 allowing for aconductive path from the conducting member 220 to the conductive medium214. Accordingly, use of the conductive epoxy 212 secures the conductingmember 220 to the assembly 202 while electrically coupling theconducting member 220 to the transducer via the conductive coating 214.

Although the transducer assembly is adapted to generate a source signaland receive a reflected signal, variations of the invention may omit thetransducer covering and other structures not necessary to generate asource signal and receive a reflected signal. Therefore, it iscontemplated that the invention may simply have a transducer that iscoupled to a controller.

FIGS. 4A–4D, illustrate possible variations of the tip 204 of thetransducer assembly. It is noted that these variations are provided forillustrative purposes and are not meant to be exhaustive. The tips 204of the present invention may function as a lens to disperse and/ordirect a signal over a substantial portion of the outer surface of thetip 204. The tip 204 also is adapted to disperse and/or direct (e.g., bydiffraction) a reflected signal towards the transducer (not shown inFIGS. 4A–4D). Accordingly, given the above described configuration, theinventive device 200 will be able to detect vessels with substantiallymost of the tip 204. The tip may comprise a signal directing means.

The tip 204 is designed such that it interferes and redirects thesignals in a desired direction in a manner like a lens. It also may bedesirable to place an epoxy between the tip 204 and the transducer.Preferably, the epoxy is thin and applied without air gaps, bubbles orpockets. Also, the density/hardness of the epoxy should provide fortransmission of the signal while minimizing any effect or change to thesource signal. The configuration of the transducer assembly 202 permitsthe tip 204 to disperse a signal over a substantial portion of its outersurface 240. The tip 204 also is adapted to refract a reflected signaltowards the transducer 208. Accordingly, given the above describedconfiguration, the inventive device will be able to detect vessels withany part or substantially all of the lens 204 that contacts tissue.

Although the tip is of the present invention is able to transmit asource signal and receive a reflected signal, the invention is notlimited to requiring both functions. For example, the inventive devicecould be configured to generate a source signal and direct the sourcesignal to an area of interest but a second device or transducer assemblycould be used to receive the reflected signal. Accordingly, a separatedevice could be used to generate the source signal with the inventivedevice being used to receive the reflected signal.

The tip 204 may be comprised of materials such as a dimethyl pentene, amethylpentene copolymer (plastic-TPX), aluminum, carbon aerogel,polycarbonate (e.g., Lexan), polystyrene, or etc., any standard materialused for ultrasound applications.

As illustrated in FIG. 4A, although the front surface 240 of the tip 202is illustrated as being hemispherical, the tip 204 may have otherprofiles as well. For example, it is desirable that the tip 204 producea certain amount of divergence of the signal being passed therethrough.However, depending on a variety of factors (e.g., material, frequency ofthe signal, etc.) a tip 204 may encounter excessive divergence which isdestructive to the outgoing signal. Accordingly, it may be desirable toproduce a tip 204 as illustrated in FIG. 4B in which a front surface 240of the tip 204 is substantially flat. The degree of flatness of the tip204 will often depend upon experimentation to reduce the amount ofdestructive reflections, thus minimizing excessive divergence due todifferences in speed of sound in tip versus tissue. For example, whenusing a tip that is conducive to an ultrasound signal (e.g., TPX) arounded tip can be used since there is not excessive divergence of thesource signal. Use of a material that is not as conducive to ultrasoundrequire a flatter tip due to the resulting divergence of the sourcesignal. FIG. 4C illustrates another variation of a tip 204 having arounded front surface 240 but with no projections on the sides of thetip 204. FIG. 4D illustrates a tip 204 with a concave front surface 240.

It may also be desirable that the device is configured such that thereare no exposed sharp edges that may cause any unintended damage totissue while the device is being used to determine the presence orabsence of a blood vessel. In such a case, for example, the tip may bedesigned such that it doesn't have sharp edges, or any sharp edges maybe covered by other parts of the device (e.g., the elongate member, anouter sheath, etc.)

FIGS. 5A–5E illustrate examples of configurations for redundant jointsto retain the tip 204 with the device by increasing the retentionstrength of the tip 204 within the device. It is contemplated that theseconcepts may be combined as necessary with the variations of theinvention disclosed herein.

FIG. 5A illustrates a tip 204 attached the transducer assembly 202. Thetip 204 may be bonded, via a retaining epoxy 230, to either thetransducer 208 or to the first conductive medium, such as a goldcoating, etc. (not shown.) Naturally, the retaining epoxy 230 should beselected to minimize any interference to the source or return signal.Examples of the retaining epoxy 230 include Epotech 301, Epotech 353,Epotech 377, provided by Epoxy Technology, Inc., Bellerica, Mass. Asillustrated in FIG. 5A, the retaining epoxy 230 may run along the sidesof the transducer assembly 202 in which case the epoxy 230 may adhere tothe elongate member (not shown.) Moreover, the tip 204 may be machined,etched, etc., to contain a plurality of small grooves 232 for seatingthe retaining epoxy 230. Such a configuration increases the retentionstrength of the tip 204 within the device and is shown in FIG. 5B whichillustrates a magnified view of the section marked 5B found in FIG. 5A.Although not shown, the epoxy 230 may be placed on a lip 234 of the lens204. In such cases, the epoxy 230 may also adhere to a front end of theelongate member (not shown.)

FIG. 5C illustrates another variation where the tip 204 has a singlegroove 246 for better retention of the tip 204 in the device. It isnoted that the grooves discussed herein may either extend around theentire perimeter of the tip 204 or they may extend over only portions ofthe tip 204. In the latter case, the term ‘groove’ is intended toinclude structures such as: dimples, furrows, indentations, pockets,notches, recesses, voids, etc. For sake of illustration, the elongatemember is not illustrated in these figures.

FIG. 5D illustrates a variation of a tip 204 having at least one rib 248which may provide a friction fit with the elongate member 218. The rib248 may be deformable or rigid.

FIG. 5E illustrates another variation of the invention where the tip hasa at least one grove 246 where the elongate member 218 is either crimpedor filled into the groove 246.

FIG. 6A illustrates a variation of the device 200 with an insulatinglayer 264 on the distal end of the device 200. The insulating layer 264may be a coating, sleeve, etc. which prevents heat generated by thehollow electrically conductive member 224 from adversely affectingeither tissue or the transducer assembly 202. The insulating layer 264may extend over a limited area of the device as needed. Examples of theinsulating layer 264 materials include polyimide, silicone, PTFE, FEP,PFA.

FIG. 6B shows a variation of the device 200 having a hollow conductivemember 224. Optionally, an insulating layer 264 may be placed betweenthe conductive member 224 and the transducer assembly 202. It is notedthat, as discussed above, the elongate member 218 itself may serve as aninsulating member.

FIG. 7A illustrates a variation of the inventive device 200 having ahollow conductive member 224 with at least one slot 268 (e.g., anyopening). The slot 268 enables portions of the sheath 226 to be insertedor formed through the slots 268 thereby providing a structure to retainthe conductive member 224 in the device. FIG. 7B shows a cross sectionalview taken along the line 7B—7B of FIG. 7A. Obviously, the sheath 226will be placed inside the slot 268 such that it does not interfere withthe transducer assembly 202 or elongate member 218. It is contemplatedthat epoxy may also be used in conjunction with this configuration.

FIGS. 8A–8C illustrates use of the device within a lung to create acollateral channel in the airway wall tissue. FIG. 8A illustrates theadvancement of an access device 120 into the airways 100 of a lung. Theaccess device may be a bronchoscope, endoscope, endotracheal tube withor without vision capability, or any type of delivery device. The accessdevice 120 will have at least one lumen or working channel 122. Theaccess device 120 will locate an approximate site 114 for creation of acollateral channel. In cases where the access device 120 is abronchoscope or similar device, the access device 120 is equipped sothat the surgeon may observe the site for creation of the collateralchannel. In some cases it may be desirable for non-invasive imaging ofthe procedure. In such cases, the access device 120 as well as the otherdevices discussed herein, may be configured for detection by theparticular non-invasive imaging technique such as fluoroscopy,“real-time” computed tomography scanning, or other technique being used.

FIG. 8B illustrates a variation of the inventive device 200 advancedthrough the channel 122 of the access device 120 towards the site 114.The site 114 is then inspected to determine whether a blood vessel isadjacent to the site.

FIG. 8C illustrates the creation of a collateral channel 112. As shownin FIG. 8C, the device 200 may be manipulated to a position that isoptimal for creation of the collateral channel 112. It is noted thateither the access device 120 or the inventive device 200 may besteerable. Such a feature may assist in the positioning of any of thedevices used in the inventive method. Although it is not illustrated, asdiscussed herein, it is desirable to create the collateral channel suchthat it is in fluid communication with an air-sac. The fluidcommunication allows for the release of trapped gasses from thehyper-inflated lung.

The inventive device is configured to communicate with an analyzingdevice or control unit 190 adapted to recognize the reflected signal ormeasure the Doppler shift between the signals. As mentioned above, thesource signal may be reflected by changes in density between tissue. Insuch a case, the reflected signal will have the same frequency as thetransmitted signal. When the source signal is reflected from bloodmoving within a vessel, the reflected signal has a different frequencythan that of the source signal. This Doppler effect permitsdetermination of the presence or absence of a blood vessel withintissue. The device may include a user interface which allows the user todetermine the presence or absence of a blood vessel at the target site.Typically, the user interface provides an audible confirmation signal.However, the confirmation signal may be manifested in a variety of ways(e.g., light, graphically via a monitor/computer, etc.)

Although depicted as being external to the device 200, it iscontemplated that the analyzing device 190 may alternatively beincorporated into the device 200. The transducer assembly of theinvention is intended to include any transducer assembly that allows forthe observation of Doppler effect, e.g., ultrasound, light, sound etc.

It should be noted that the invention includes kits containing theinventive device with any one or more of the following components, an RFenergy supply, a Doppler ultrasound controller, a conduit as describedin one or more of the applications listed above, and abronchoscope/endoscope.

1. A medical device for applying energy to tissue, the medical devicecomprising: an elongate member having a proximal portion and a distalportion; a transducer assembly comprising a covering having a proximaland distal end, at least one transducer having at least a first andsecond pole, a first conductive medium in contact with said first poleof said transducer and extending to at least a portion of an outersurface of said covering, wherein said transducer assembly is locatedtowards a distal end of said elongate member distal portion; at leasttwo conducting members extending through at least a portion of saidelongate member, at least a first of said conducting members beingelectrically coupled to said first conductive medium, and a second ofsaid conducting members extending through said proximal end of saidcovering and electrically coupled to said second pole of saidtransducer; a hollow conductive member located at the distal end of saidelongate member, said hollow conductive member electrically coupled toan energy source, and a tip located at a distal end of said elongatemember distal portion and having a front and back surface, said backsurface being in acoustical communication with said transducer such thatsaid tip is adapted to communicate a source signal from said transducerout through said front surface, said tip also being adapted tocommunicate a reflected signal from said front surface to saidtransducer assembly.
 2. The medical device of claim 1, wherein said tipcomprises a methylpentene copolymer.
 3. The medical device of claim 1,wherein said front surface of said tip is round.
 4. The medical deviceof claim 1, wherein said front surface of said tip is flat.
 5. Themedical device of claim 1, wherein said front surface of said tip isconcave.
 6. The medical device of claim 1, further comprising aretaining epoxy placed adjacent to said tip to assist in retaining saidtip to the device.
 7. The medical device of claim 6, wherein a surfaceof said tip adjacent to said elongate member contains at least onegroove, wherein said retaining epoxy fills said groove to increaseretention of said tip.
 8. The medical device of claim 6, wherein saidretaining epoxy is located at least between said tip and saidtransducer.
 9. The medical device of claim 1, wherein said elongatemember comprises an insulating material.
 10. The medical device of claim1, further comprising an insulating layer over a portion of saidelongate member.
 11. The medical device of claim 1, further comprisingan outer sheath having a proximal and distal ends and a lumen extendingtherethrough, wherein said elongate member is located within said sheathlumen.
 12. The medical device of claim 1, wherein said hollow conductivemember is coupled to said energy source via a third conducting member.13. The medical device of claim 12, wherein said energy source is an RFenergy source.
 14. The medical device of claim 1, wherein said hollowconductive member comprises a material selected from the groupconsisting of stainless steel, titanium, and aluminum.
 15. The medicaldevice of claim 1, wherein said hollow conductive member includes atleast one slot and wherein a portion of an outer sheath member isretained within said at least one slot.
 16. The medical device of claim1, wherein said first and second conducting members are electricallycoupled to a control unit to measure the Doppler shift between thetransmitted and received signals.
 17. The medical device of claim 1,said transducer is a piezo-electric ultrasound transducer.
 18. Themedical device of claim 1, wherein said covering comprises a first tube.19. The medical device of claim 18, wherein said first tube isconductive.
 20. The medical device of claim 1, wherein said transducerassembly further comprises a second tube placed within said covering andhaving an end placed adjacent to said transducer.
 21. The medical deviceof claim 20, wherein said second tube is conductive and where saidsecond conducting member is electrically coupled to said second tube.22. The medical device of claim 1, further comprising a non-conductiveepoxy within said covering, said non-conductive epoxy securing a portionof said second conducting member within said covering.
 23. The medicaldevice of claim 22, wherein a portion of said transducer is separatedfrom said non-conductive epoxy by a gap.
 24. The medical device of claim22, further comprising a conductive epoxy at a proximal end of saidtransducer assembly, said conductive epoxy electrically coupling saidfirst conducting member with said first conductive medium.
 25. Themedical device of claim 1, wherein said hollow conductive member isfixed in position relative to said transducer assembly.
 26. The medicaldevice of claim 1, wherein said hollow conductive member is slidablerelative to said transducer assembly.
 27. A medical device for detectingDoppler shift and for applying energy to tissue, the medical devicecomprising: an elongate member having a proximal portion and a distalportion; a transducer assembly comprising at least one transducer havingat least a first and second pole, a first conductive medium in contactwith said first pole of said transducer, wherein at least a portion ofsaid transducer assembly is located towards said distal portion of saidelongate member; a tip having a back surface being in acousticalcommunication with said transducer such that said transducer is able totransmit and receive a signal having a wavelength to/from said tip; afirst conducting member and a second conducting member both extendingthrough at least a portion of said elongate member, said firstconducting member being electrically coupled to said first conductivemedium, and said second conducting member being electrically coupled tosaid second pole of said transducer; an outer sheath having a hollowconductive member located at a distal end of said sheath, said sheathand conductive member located about an exterior of said elongate member,said sheath and said elongate member slidable relative to one another;and a third conducting member electrically coupling an RF power supplyelectrically coupled to said hollow conductive member.